Zilucoplan sodium - Generic Drug Details

What are the generic sources for zilucoplan sodium and what is the scope of freedom to operate?

Zilucoplan sodium is the generic ingredient in one branded drug marketed by Ucb Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zilucoplan sodium has one hundred and thirty-four patent family members in thirty countries.

One supplier is listed for this compound.

Summary for zilucoplan sodium

International Patents:	134
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	zilucoplan sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for zilucoplan sodium

Constraining patent/regulatory exclusivity:

TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for zilucoplan sodium

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for zilucoplan sodium

L04AJ	Complement inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for zilucoplan sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-001	Oct 17, 2023		RX	Yes	Yes	10,835,574		Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-002	Oct 17, 2023		RX	Yes	Yes	11,014,965			Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-002	Oct 17, 2023		RX	Yes	Yes	10,562,934			Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-002	Oct 17, 2023		RX	Yes	Yes	10,435,438			Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes

International Patents for zilucoplan sodium

Country	Patent Number	Title	Estimated Expiration
Poland	3628680
Croatia	P20230182
South Africa	201706379	MODULATION OF COMPLEMENT ACTIVITY
South Korea	20180094913	보체 활성의 조절인자
Japan	2019504012	補体活性のモジュレーター
Australia	2016370210	Modulators of complement activity

Supplementary Protection Certificates for zilucoplan sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3154561	17/2024	Austria		PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 (MITTEILUNG) 20231204
3154561	301275	Netherlands		PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 20231204
3154561	PA2024514	Lithuania		PRODUCT NAME: ZILUKOPLANAS; REGISTRATION NO/DATE: EU/1/23/1764 20231201
3154561	CA 2024 00021	Denmark		PRODUCT NAME: ZILUCOPLAN; REG. NO/DATE: EU/1/23/1764 20231204
3154561	2024C/518	Belgium		PRODUCT NAME: ZILUCOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1764 20231204
3154561	LUC00343	Luxembourg		PRODUCT NAME: ZILUCOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1764 20231204

Zilucoplan sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zilucoplan Sodium

Introduction to Zilucoplan Sodium

Zilucoplan, marketed as ZILBRYSQ®, is a selective C5 (complement component 5) peptide inhibitor developed by UCB Biopharma for the treatment of generalized myasthenia gravis (gMG) in adult patients. This drug has recently gained significant attention due to its FDA approval and its potential to transform the treatment landscape for gMG.

Mechanism of Action and Clinical Significance

Zilucoplan targets the C5 component of the terminal complement activation pathway, preventing its cleavage into C5a and C5b. This mechanism is crucial in reducing the inflammatory and immune-mediated damage associated with gMG[1][2][4].

Clinical Trials and Efficacy

The Phase 3 RAISE trial demonstrated that zilucoplan resulted in statistically significant improvements in key gMG-specific outcomes, including the Myasthenia Gravis Activities of Daily Living (MG-ADL) score and the Quantitative Myasthenia Gravis (QMG) score. These improvements were observed as early as Week 1 and were sustained through Week 12[2][4].

Regulatory Milestones

Zilucoplan received FDA approval in October 2023 for the treatment of gMG in adult patients. This approval marks a significant milestone, as it provides patients with a self-administered, once-daily, subcutaneous treatment option, which is more convenient than traditional intravenous therapies[2].

Market Forecast and Sales Projections

The market forecast for zilucoplan is promising, with projected sales data available from 2024 to 2032. The report by DelveInsight provides a comprehensive market assessment, including forecasted sales in the seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. This data is crucial for stakeholders to understand the potential market size and penetration of zilucoplan[1].

Competitive Landscape

UCB's portfolio now includes two targeted therapies for gMG: zilucoplan and rozanolixizumab (RYSTIGGO®). This dual offering positions UCB uniquely in the market, providing healthcare professionals with options to address either complement activation or pathogenic auto-antibodies, depending on the patient's needs. Other emerging therapies are also expected to enter the market, which could impact zilucoplan's market share[2][4].

SWOT Analysis and Analyst Views

The SWOT analysis for zilucoplan highlights its strengths, such as its novel mechanism of action, rapid and consistent efficacy, and convenient administration. However, it also notes potential weaknesses, including competition from other emerging therapies and the need for continuous regulatory approvals. Analyst views suggest that zilucoplan has a strong potential to dominate the gMG market due to its clinical efficacy and patient-friendly administration[1].

Financial Implications and Revenue Potential

The financial trajectory of zilucoplan is expected to be robust, driven by its FDA approval and the growing demand for effective gMG treatments. The forecasted sales data indicate a significant revenue potential, especially considering the lack of convenient and effective treatments in the past. UCB's commitment to widespread access and tailored patient support services further enhances the financial outlook for zilucoplan[1][2].

Patient and Market Impact

For patients with gMG, zilucoplan offers a transformative treatment option that can significantly improve their quality of life. The drug's ability to reduce muscle weakness and fatigue, and its ease of administration, make it a preferred choice. This impact is expected to drive market demand and contribute to the drug's financial success[2].

Challenges and Opportunities

Despite the positive outlook, there are challenges to consider, such as the global spread of COVID-19, changes in economic and competitive conditions, and the need for ongoing regulatory approvals. However, these challenges also present opportunities for UCB to innovate and adapt, ensuring zilucoplan remains a market leader[1][4].

Real-World Data and Patient Support

UCB's commitment to real-world data collection and patient support services is a key factor in zilucoplan's market dynamics. The use of smartphone data collection studies and tailored patient support services enhances patient outcomes and satisfaction, which can drive long-term market success[4].

Safety and Tolerability

The safety profile of zilucoplan has been favorable, with common adverse reactions including injection site reactions, upper respiratory tract infections, and diarrhea. The drug's tolerability and safety data from clinical trials are crucial for its market acceptance and continued use[2][4].

Patent and Expiry Timeline

The report by DelveInsight also covers the patent information and expiry timeline for zilucoplan, which is essential for understanding the drug's long-term market protection and potential generic competition[1].

Global Market Expansion

With FDA approval in place, UCB is poised to expand zilucoplan's availability globally. The drug's performance in the seven major markets will be a key indicator of its global market potential and financial trajectory[1][2].

Key Takeaways

• FDA Approval: Zilucoplan has been approved by the FDA for the treatment of gMG in adult patients.
• Clinical Efficacy: The drug has demonstrated statistically significant improvements in gMG-specific outcomes.
• Market Forecast: Projected sales data indicate a strong market potential from 2024 to 2032.
• Competitive Landscape: UCB's dual therapy offering positions zilucoplan competitively in the gMG market.
• Financial Trajectory: The drug is expected to generate significant revenue due to its efficacy and patient-friendly administration.

FAQs

What is the mechanism of action of zilucoplan?

Zilucoplan is a selective C5 peptide inhibitor that prevents the cleavage of C5 into C5a and C5b, thereby reducing inflammatory and immune-mediated damage associated with gMG[1][2][4].

What are the key clinical trial results for zilucoplan?

The Phase 3 RAISE trial showed statistically significant improvements in MG-ADL and QMG scores, with benefits observed as early as Week 1 and sustained through Week 12[2][4].

What is the dosing regimen for zilucoplan?

Zilucoplan is administered subcutaneously once daily at a nominal dose level of 0.3 mg/kg, supplied in prefilled syringes of various doses based on patient weight[2][5].

What are the common adverse reactions associated with zilucoplan?

Common adverse reactions include injection site reactions, upper respiratory tract infections, and diarrhea[2][4].

How does zilucoplan compare to other treatments for gMG?

Zilucoplan offers a convenient self-administered option, contrasting with traditional intravenous therapies. It also provides a distinct mechanism of action compared to other emerging therapies like rozanolixizumab[2][4].

Cited Sources

1. Zilucoplan Emerging Drug Insight and Market Forecast – 2032 - DelveInsight
2. UCB announces U.S. FDA approval of ZILBRYSQ® (zilucoplan) for the treatment of generalized myasthenia gravis - UCB
3. Therapeutic Peptides Targeting PPI in Clinical Development - Frontiers in Molecular Biosciences
4. UCB presents efficacy and safety results for zilucoplan and rozanolixizumab in generalized myasthenia gravis - UCB
5. 216834Orig1s000 OTHER REVIEW(S) - FDA